Massachusetts
Dr. Stephen Amato has over 24 years of experience in Healthcare: Pharmaceuticals and Law & Legal: FDA & Drug Safety. He earned his BA in Biochemical Sciences from Harvard University, his Ph.D. in Molecular and Cellular Biology from Boston College, and his MBA in Marketing from Boston College. Today, this expert has Regulatory Affairs Certification by the Regulatory Affairs Professional Society...
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Deposition Fee
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An FDA Regulations expert witness provides insight on compliance, regulatory standards, and industry practices. They can testify on violations, product safety, and approval processes.
Cases involving pharmaceuticals, medical devices, food safety, dietary supplements, cosmetics, or any product regulated by the FDA may require such an expert witness.
Yes. These experts can provide valuable insights into the complex process of drug approval and how deviations from this process can lead to legal issues.
Yes. Subspecialties can include pharmaceutical regulations, food safety standards, medical device regulations, cosmetic regulations, and more.
They can evaluate whether the manufacturer complied with FDA regulations regarding reporting adverse events and if failure to comply contributed to harm.
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